02 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Boehringer Ingelheim Biopharmaceuticals has installed a fast track process transfer to commercial scale. Companies that outsource their biopharmaceutical phase III projects to Boehringer Ingelheim can now benefit from its proven ‘Smart-to-Launch' processes.
The processes shorten the timelines from kick-off to drug substance availability and completion of the CMC regulatory package (Chemistry, Manufacturing and Controls) to just eight months and 15 months, respectively, without compromises on quality.
Boehringer Ingelheim's fill and finish service can be seamlessly integrated to deliver drug products to customers as fast as 17 months from kick off to completion of CMC package. ‘Smart-to-Launch' is available for both mammalian and microbial projects.
"We have developed ‘Smart-to-Launch' over the last years and have already received positive customer feedback", commented Dr Uwe Buecheler, senior VP, global biopharma operations, Boehringer Ingelheim. "'Smart-to-Launch' significantly speeds up project transfers, scale up, process validation and clinical phase III supplies and can bring our customers cost-and timeline advantages."